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Claims for Patent: 8,591,938

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Claims for Patent: 8,591,938

Title:Liquid compositions of calcium acetate
Abstract: The invention relates to an aqueous liquid composition of calcium acetate, sweetener, and taste masking agent. Also provided is a method for binding phosphorus within the gastrointestinal tract of an individual by administering to the individual an aqueous solution of at least calcium acetate.
Inventor(s): Tarallo; Stephen C. (Brockton, MA)
Assignee: Lyne Laboratories, Inc. (Brockton, MA)
Application Number:11/878,169
Patent Claims: 1. An oral dosage form of calcium acetate comprising a liquid pharmaceutical composition comprising an aqueous solution of: (a) 7-16% calcium acetate (w/v), (b) an artificial sweetener selected from the group consisting of sucralose, acesulfame potassium, aspartame and saccharin, (c) a polyol selected from the group consisting of sorbitol, glycerine, propylene glycol, xylitol, maltitol, and combinations thereof, and (d) a taste masking agent comprising monoammonium glycyrrhizinate.

2. The oral dosage form according to claim 1, wherein the calcium acetate is present in a concentration of from about 12% (w/v) to about 16% (w/v) based on the total volume of the composition.

3. The oral dosage form according to claim 2, wherein the calcium acetate is present in a concentration of about-14% (w/v).

4. The oral dosage form according to claim 1, wherein the total concentration of polyol is from about 15% (w/v) to about 50% (w/v) based on the total volume of the composition.

5. The oral dosage form according to claim 1, wherein said composition comprises from about-15% (w/v) to about 40% (w/v) of sorbitol.

6. The oral dosage form according to claim 1, wherein said composition comprises about 21% (w/v) sorbitol.

7. The oral dosage form according to claim 1, wherein said composition comprises from about 15% (w/v) to about 25% (w/v) maltitol.

8. The oral dosage form according to claim 7, wherein said composition comprises about 20% (w/v) maltitol.

9. The oral dosage form according to claim 6, wherein said composition further comprises from about 1% (w/v) to about 25% (w/v) of glycerine.

10. The oral dosage form according to claim 9, wherein the glycerine is present at a concentration of about 5% (w/v).

11. The oral dosage form according to claim 1, wherein said artificial sweetener is selected from the group consisting of sucralose and saccharin.

12. The oral dosage form according to claim 11, wherein said sucralose is present at a concentration of about 0.35% (w/v) or said saccharin is present at a concentration of about 0.15% (w/v).

13. The oral dosage form according to claim 1, further comprising at least one flavoring agent.

14. The oral dosage form according to claim 13, wherein said flavoring agent is selected from the group consisting of berry flavor, root beer flavor, cream flavor, chocolate flavor, peppermint flavor, spearmint flavor and wintergreen flavor.

15. The oral dosage form according to claim 14, further comprising menthol flavor.

16. The oral dosage form according to claim 13, wherein said flavoring agent is black cherry flavor.

17. The oral dosage form according to claim 16, wherein said black cherry flavor is artificial black cherry flavor.

18. The oral dosage form according to claim 1, further comprising at least one preservative.

19. The oral dosage form according to claim 18, wherein said preservative is selected from the group consisting of: methylparaben, propylparaben, sorbic acid, sodium benzoate, potassium sorbate and combinations thereof.

20. The oral dosage form according to claim 19, wherein said preservative is methylparaben.

21. The oral dosage form according to claim 20, further comprising polyvinylpyrrolidone (PVP).

22. The oral dosage form according to claim 18, wherein said polyol comprises propylene glycol.

23. The oral dosage form according to claim 1, wherein the pH of the composition is from about 6.0 to about 7.2.

24. The oral dosage form according to claim 1, comprising about 21% (w/v) sorbitol, about 14% (w/v) calcium acetate, about 5% (w/v) glycerine, about 2% (w/v) propylene glycol, about 0.25% (w/v) monoammonium glycyrrhizinate, about 0.35% (w/v) sucralose, about 0.75% (w/v) polyvinylpyrrolidone, about 0.2% (w/v) methylparaben, about 0.2% (w/v) artificial black cherry flavor, and about 0.2% (w/v) menthol flavor.

25. The oral dosage form according to claim 1, comprising about 20% (w/v) maltitol, about 14% (w/v) calcium acetate, about 5% (w/v) glycerine, about 2% (w/v) propylene glycol, about 0.25% (w/v) monoammonium glycyrrhizinate, about 0.35% (w/v) sucralose, about 0.75% (w/v) polyvinylpyrrolidone, about 0.2% (w/v) methylparaben, about 0.2% (w/v) artificial black cherry flavor, and about 0.2% (w/v) menthol flavor.

26. The oral dosage form of claim 1, wherein 5 milliliters of said composition contains about 710 milligrams of hydrous calcium acetate.

27. The oral dosage form of claim 1, wherein 5 milliliters of said composition contains about 667 milligrams of anhydrous calcium acetate.

28. The oral dosage form of claim 1, wherein 5 milliliters of said composition contains about 169 milligrams of calcium.

29. The oral dosage form of claim 1, wherein said composition is sugar-free.

30. The oral dosage form of claim 1, wherein said composition is low-calorie.

31. The oral dosage form of claim 1, wherein said composition is calorie-free.

32. The oral dosage form of claim 1, which comprises about 8 milliequivalents of calcium.

33. A method for binding phosphorus within the gastrointestinal tract of an individual, comprising orally administering to said individual a liquid pharmaceutical composition comprising an aqueous solution comprising: from 7% (w/v) to 16% (w/v) of calcium acetate, an artificial sweetener selected from the group consisting of sucralose, acesulfame potassium, aspartame and saccharin, a polyol selected from the group consisting of sorbitol, glycerine, propylene glycol, xylitol, maltitol, and combinations thereof, and a taste masking agent comprising monoammonium glycyrrhizinate.

34. The method according to claim 33, wherein the individual is in need of dialysis and/or is suffering from one or more of the following disorders: renal disease, kidney disease, end stage renal disease, chronic kidney disease.

35. The method according to claim 33, wherein the composition comprises: calcium acetate in a concentration of about 12% (w/v) to about 16% (w/v) based on the total volume of the composition.

36. The method according to claim 33, wherein the calcium acetate is present in a concentration of about 14% (w/v).

37. The method according to claim 33, wherein the total concentration of polyol in the composition is about 15% (w/v) to about 50% (w/v) based on the total volume of the composition.

38. The method according to claim 33, wherein said composition comprises about 15% (w/v) to about 40% (w/v) of sorbitol based on the total volume of the composition.

39. The method according to claim 33, wherein said composition comprises about 21% (w/v) sorbitol.

40. The method according to claim 33, wherein said composition comprises about 15% (w/v) to about 25% (w/v) maltitol based on the total volume of the composition.

41. The method according to claim 33, wherein said composition comprises about 20% (w/v) maltitol.

42. The method according to claim 33, wherein said composition further comprises about 1% (w/v) to about 25% (w/v) of glycerine based on the total volume of the composition.

43. The method according to claim 42, wherein said glycerine is present at a concentration of about 5% (w/v).

44. The method according to claim 33, wherein said artificial sweetener is selected from the group consisting of sucralose and saccharin.

45. The method according to claim 44, wherein said sucralose is present at a concentration of about 0.35% (w/v) or said saccharin is present at a concentration of about 0.15% (w/v) based on the total volume of the composition.

46. The method according to claim 33, wherein said composition further comprises at least one flavoring agent.

47. The method according to claim 46, wherein said flavoring agent is selected from the group consisting of menthol, berry flavor, root beer flavor, cream flavor, chocolate flavor, peppermint flavor, spearmint flavor and wintergreen flavor.

48. The method according to claim 47, wherein said flavoring agent is black cherry flavor.

49. The method according to claim 48, wherein said black cherry flavor is artificial black cherry flavor.

50. The method according to claim 48, wherein said composition further comprises menthol flavor.

51. The method according to claim 33, wherein said composition further comprises at least one preservative.

52. The method according to claim 51, wherein said preservative is selected from the group consisting of methylparaben, propylparaben, sorbic acid, sodium benzoate, potassium sorbate and combinations thereof.

53. The method according to claim 52, wherein said preservative comprises methylparaben.

54. The method according to claim 33, wherein said composition comprises polyvinylpyrrolidone (PVP).

55. The method according to claim 33, wherein said polyol comprises propylene glycol.

56. The method according to claim 33, wherein said composition has pH of about 6.0 to about 7.2.

57. The method of claim 33, wherein said composition comprises about 21% (w/v) sorbitol, about 14% (w/v) calcium acetate, about 5% (w/v) glycerine, about 2% (w/v) propylene glycol, about 0.25% (w/v) monoammonium glycyrrhizinate, about 0.35% (w/v) sucralose, about 0.75% (w/v) polyvinylpyrrolidone, about 0.2% (w/v) methylparaben, about 0.2% (w/v) artificial black cherry flavor, and about 0.2% (w/v) menthol flavor.

58. The method of claim 33, wherein said composition comprises about 20% (w/v) maltitol, about 14% (w/v) calcium acetate, about 5% (w/v) glycerine, about 2% (w/v) propylene glycol, about 0.25% (w/v) monoammonium glycyrrhizinate, about 0.35% (w/v) sucralose, about 0.75% (w/v) polyvinylpyrrolidone, about 0.2% (w/v) methylparaben, about 0.2% (w/v) artificial black cherry flavor, and about 0.2% (w/v) menthol flavor.

59. The method of claim 33, wherein 5 milliliters of said composition contains about 710 milligrams of hydrous calcium acetate.

60. The method of claim 33, wherein 5 milliliters of said composition contains about 667 milligrams of anhydrous calcium acetate.

61. The method of claim 33, wherein 5 milliliters of said composition contains about 169 milligrams of calcium.

62. The method of claim 33, wherein said composition is sugar-free.

63. The method of claim 33, wherein said composition is a low-calorie composition.

64. The method of claim 33, wherein said composition is calorie-free.

65. The method of claim 33, wherein said composition comprises about 8 milliequivalents of calcium.

66. The method according to claim 33, wherein the individual is suffering from hyperphosphatemia.

67. The method according to claim 33, wherein the method comprises administering about one tablespoon (15 mL) of said composition three times per day.

68. The method according to claim 33, wherein the method comprises administering said composition around the time of ingestion of a meal.
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